Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 5:32 PM
Ignite Modification Date: 2025-12-25 @ 3:05 PM
NCT ID: NCT00610168
Description: None
Frequency Threshold: 5
Time Frame: Solicited local/general symtopms: during the 4-day post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to Month 1).
Study: NCT00610168
Study Brief: Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Boostrix Pooled Group Boostrix I and Boostrix II Groups pooled together. None None 1 82 78 82 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyperventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Redness SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fever (Axillary) SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View